BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 16468947 · Received March 2, 2023

    Report

    Report Number
    2210968-2023-01420
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    February 16, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031062375
    PMA / PMN Number
    K132054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE ¿ F, 176LBS, 29.29. NAME OF INDEX SURGICAL PROCEDURE? SLING OPERATION FOR STRESS INCONTINENCE THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? STRESS INCONTINENCE WERE ANY CONCOMITANT PROCEDURES PERFORMED? YES. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? NOTED. LOCATION AND CHARACTER OF PAIN? ABDOMINAL PAIN. PLEASE DESCRIBE ANY MEDICAL INTERVENTION GIVEN FOR PAIN MANAGEMENT INCLUDING MEDICATION NAME AND RESULTS. HYDROMORPHONE. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? POSSIBLY RELATED TO STUDY DEVICE AND STUDY PROCEDURE. WHAT IS THE PATIENT'S CURRENT STATUS? PAIN IS CONTROLLED. PRODUCT CODE AND LOT NUMBER? TVTRL - 3942544. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. UPDATED INFORMATION RECEIVED: ADVERSE EVENT TERM : STRESS INCONTINENCE: PERSISTENT STRESS INCONTINENCE. OUTCOME : NOT RECOVERED/NOT RESOLVED: RECOVERED/RESOLVED WITHOUT SEQUELAE.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION RECEIVED: ADVERSE EVENT TERM: POST OP PAIN. UPDATED: END DATE : BLANK : (B)(6) 2023. OUTCOME : NOT RECOVERED/NOT RESOLVED : RECOVERED/RESOLVED WITHOUT SEQUELAE. NEW ADVERSE EVENT TERM: STRESS INCONTINENCE. START DATE: (B)(6) 2023. SEVERITY: MILD. RELATIONSHIP TO STUDY DEVICE: POSSIBLE. RELATIONSHIP TO PRIMARY STUDY PROCEDURE: POSSIBLE. NON-SURGICAL PROCEDURE, THERAPY, OR INTERVENTION: YES. SPECIFY: REFERRAL TO PT. OUTCOME: NOT RECOVERED/NOT RESOLVED. NEW ADVERSE EVENT TERM: URGENCY INCONTINENCE. START DATE: (B)(6) 2023. SEVERITY: MILD. RELATIONSHIP TO STUDY DEVICE: POSSIBLE. RELATIONSHIP TO PRIMARY STUDY PROCEDURE: POSSIBLE. NON-SURGICAL PROCEDURE, THERAPY, OR INTERVENTION: YES. SPECIFY: REFERRAL TO PT. OUTCOME: NOT RECOVERED/NOT RESOLVED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. UPDATED INFORMATION RECEIVED: ADVERSE EVENT TERM: URGENCY INCONTINENCE. SPECIFY: REFERRAL TO PT PELVIC FLOOR PHYSICAL THERAPY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE FOR STRESS INCONTINENCE ON (B)(6) 2023 AND MESH WAS IMPLANTED. ON (B)(6) 2023, THE PATIENT EXPERIENCED MODERATE POST-OP ABDOMINAL PAIN AND WAS PROVIDED HYDROMORPHONE FOR DRUG THERAPY. THE EVENT WAS REPORTED AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE. THE PAIN HAS BEEN CONTROLLED, BUT NOT RECOVERED/NOT RESOLVED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516608 TVT EXACT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. TVTRL 3942544 10705031062375

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention